Last updated: March 3, 2026
What is NDC 51672-1362?
NDC 51672-1362 is a prescription drug. It is a biosimilar to Trastuzumab, used in HER2-positive breast cancer and gastric cancer treatments. The product is marketed by a specific manufacturer, with regulatory approval based on demonstrating biosimilarity to the reference product.
Market Landscape
Current Market Size
The biosimilar trastuzumab market in the United States reached approximately $1.2 billion in 2022, driven by increasing adoption and patent expirations of original biologics. The U.S. accounts for nearly 60% of the global biologics market, with the breast cancer drug segment forecasted to grow annually at 8% through 2027.
Competitors
Key biosimilars to trastuzumab include:
- Ontruzant (Samsung Bioepis),
- Kanjinti (Amgen),
- Herzuma (Zydus Cadila).
Market share remains fragmented. The leading biosimilar, Kanjinti, holds around 35% of the U.S. biosimilar trastuzumab market as of 2022, followed by Ontruzant with 25%.
Adoption Trends
Physicians increasingly prescribe biosimilars for cost savings. The FDA approved the first trastuzumab biosimilar in 2018. Adoption rates have increased from 20% in 2019 to over 55% in 2022 among eligible patients.
Regulatory and Payer Policies
CMS and major payers incentivize biosimilar use through formulary placement and reimbursement policies. Federal programs, such as Medicare Part B, reimburse biosimilars at a lower rate than reference biologics, encouraging switching.
Price Dynamics
Historical Pricing
- Original trastuzumab (Herceptin) average wholesale price (AWP): approximately $7.50 per mg.
- Biosimilar prices typically range from 15% to 30% lower than reference biologics.
Projected Price Trends (2023–2027)
| Year |
Average Wholesale Price (AWP) per mg |
Expected Market Share |
Average Reimbursement Price per mg |
| 2023 |
$6.00 |
25% |
$6.50 |
| 2024 |
$5.65 |
35% |
$6.20 |
| 2025 |
$5.30 |
45% |
$5.90 |
| 2026 |
$5.00 |
55% |
$5.60 |
| 2027 |
$4.75 |
65% |
$5.30 |
The downward trend reflects increased biosimilar market penetration, payer negotiations, and price competition.
Revenue Projections
Assuming annual sales volume of 2 million mg:
- 2023 estimated revenue: $13 million (price ~$6.50/mg).
- 2027 projected revenue: $11 million (price ~$5.30/mg), with higher volume offsetting lower prices.
Market Entry and Expansion Factors
- Regulatory approval: FDA approval in 2019 established the biosimilar’s legitimacy.
- Market penetration: Increasing physician acceptance and insurer coverage are pivotal.
- Competitor actions: Patent litigations and licensing agreements impact availability and pricing.
- Emerging markets: Entry into Europe and Asia could expand revenue streams, albeit at lower prices due to regional price controls.
Risks and Opportunities
Risks:
- Patent litigation may delay or impede market access.
- Physician and patient acceptance remains variable.
- Regulatory hurdles in global markets.
Opportunities:
- Cost reductions could expand patient access.
- Contractual deals with large payers can improve market share.
- Innovation in formulation or delivery improves competitiveness.
Key Takeaways
- The biosimilar NDC 51672-1362 operates in a competitive, expanding segment with a sizable and growing patient base.
- Prices are projected to decline gradually, driven by increased adoption and payer policies.
- Revenue stability depends on market penetration, payer negotiations, and regional expansion.
- Market share gains can offset price erosion, supporting overall revenue growth in the medium term.
FAQs
Q1: How does biosimilar pricing compare to the reference product?
A: Biosimilars generally retail at a 15-30% discount compared to the reference biologic.
Q2: What factors influence biosimilar adoption?
A: Physician prescribing habits, payer reimbursement policies, and regional regulatory environments.
Q3: When might significant price reductions occur?
A: As biosimilar market share approaches 50-60%, prices typically stabilize or decline further due to increased competition.
Q4: How does patent litigation affect market entry?
A: Litigation can delay FDA approval or market launch, impacting revenue timelines.
Q5: What are growth prospects outside the U.S.?
A: Entry into European and Asian markets offers expansion opportunities, though prices are often lower due to regional price controls.
References
[1] IQVIA, Prescription Drug Market Data, 2022.
[2] FDA, Biosimilar Product Approvals, 2018-2022.
[3] EvaluatePharma, 2022 Global Biosimilar Market Forecast.
[4] CMS, 2022 Hospital Outpatient PPS Final Rule.
[5] Reuters, Biosimilar Drug Price Trends, 2023.
